Adverse event management in patients with relapsed and refractory multiple myeloma taking pomalidomide plus low-dose dexamethasone: A pooled analysis

被引:15
|
作者
Moreau, Philippe [1 ]
Dimopoulos, Meletios A. [2 ]
Richardson, Paul G. [3 ]
Siegel, David S. [4 ]
Cavo, Michele [5 ]
Corradini, Paolo [6 ]
Weisel, Katja [7 ]
Delforge, Michel [8 ]
O'Gorman, Peter [9 ]
Song, Kevin [10 ]
Chen, Christine [11 ]
Bahlis, Nizar [12 ]
Oriol, Albert [13 ]
Hansson, Markus [14 ]
Kaiser, Martin [15 ]
Anttila, Pekka [16 ,17 ]
Raymakers, Reinier [18 ]
Joao, Cristina [19 ,20 ]
Cook, Gordon [21 ]
Sternas, Lars [22 ]
Biyukov, Tsvetan [23 ]
Slaughter, Ana [23 ]
Hong, Kevin [22 ]
Herring, Jennifer [22 ]
Yu, Xin [22 ]
Zaki, Mohamed [22 ]
San-Miguel, Jesus [24 ]
机构
[1] Univ Hosp Hotel Dieu, Nantes, France
[2] Univ Athens, Athens, Greece
[3] Dana Farber Canc Inst, Boston, MA 02115 USA
[4] Hackensack Univ, John Theurer Canc Ctr, Med Ctr, Hackensack, NJ USA
[5] Bologna Univ, Sch Med, Bologna, Italy
[6] Univ Milan, Fdn IRCCS Ist Nazl Tumori, Milan, Italy
[7] Univ Hosp Tuebingen, Tubingen, Germany
[8] Univ Hosp Leuven, Leuven, Belgium
[9] Univ Coll Dublin, Mater Misericordiae Univ Hosp, Dublin, Ireland
[10] Vancouver Gen Hosp, Vancouver, BC, Canada
[11] Princess Margaret Hosp, Toronto, ON, Canada
[12] Univ Calgary, Tom Baker Canc Ctr, Calgary, AB, Canada
[13] Hosp Badalona Germans Trias & Pujol, Inst Josep Carreras, Inst Catala Oncol, Barcelona, Spain
[14] Lund Univ, Skane Univ Hosp, Lund, Sweden
[15] Royal Marsden Hosp, Surrey, England
[16] Univ Helsinki, Helsinki, Finland
[17] Helsinki Univ Hosp, Comprehens Canc, Helsinki, Finland
[18] Univ Med Ctr Utrecht, Utrecht, Netherlands
[19] NOVA Univ, Champalimaud Fdn Unknown, Hematooncol Dept, Lisbon, Portugal
[20] NOVA Univ, Fac Ciencias Med, Lisbon, Portugal
[21] St James Univ Hosp, St Jamess Inst Oncol, Leeds, W Yorkshire, England
[22] Celgene Corp, Summit, NJ USA
[23] Celgene Int Sarl, Boudry, Switzerland
[24] Clin Univ Navarra, CIMA, IDISNA, Pamplona, Spain
关键词
dexamethasone; pomalidomide; pooled analysis; relapsed and refractory multiple myeloma; safety; CONSENSUS STATEMENT; RENAL IMPAIRMENT; LENALIDOMIDE; BORTEZOMIB; EFFICACY; SAFETY; MM-003;
D O I
10.1111/ejh.12903
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
ObjectivesHeavily pretreated patients with relapsed and refractory multiple myeloma are susceptible to treatment-related adverse events (AEs). Managing AEs are important to ensure patients continue therapy long enough to receive the best clinical benefit. Data from the MM-002, MM-003, and MM-010 trials were pooled to further characterize the safety profile of pomalidomide plus low-dose dexamethasone and AE management. MethodsThis analysis included 1088 patients who received 2 prior therapies, including lenalidomide and bortezomib, and progressed 60days of last therapy. Patients received 28-day cycles of pomalidomide 4mg/day on days 1-21 and low-dose dexamethasone 40mg (20mg if aged > 75years) weekly until disease progression or unacceptable toxicity. Thromboprophylaxis was required. ResultsThe most common grade 3/4 AEs were neutropenia (56.2%), anemia (32.3%), and thrombocytopenia (25.8%), which occurred within the first few cycles of treatment. Grade 3/4 infections occurred in 33.7% patients, of whom 13.9% had pneumonia, and 40.3% had neutropenia. Pomalidomide dose reductions or interruptions were reported in 24.2% and 66.0% of patients, respectively. AEs were managed by dose modifications and/or supportive care. ConclusionsPomalidomide plus low-dose dexamethasone showed an acceptable safety profile, and AEs were well managed according to study protocols and established guidelines.
引用
收藏
页码:199 / 206
页数:8
相关论文
共 50 条
  • [1] MANAGEMENT OF ADVERSE EVENTS IN PATIENTS WITH RELAPSED AND REFRACTORY MULTIPLE MYELOMA TREATED WITH POMALIDOMIDE PLUS LOW-DOSE DEXAMETHASONE: A POOLED SAFETY ANALYSIS OF 3 CLINICAL TRIALS
    Moreau, P.
    Dimopoulos, M. A.
    Richardson, P. G.
    Siegel, D.
    Palumbo, A.
    Cavo, M.
    Corradini, P.
    Weisel, K.
    Delforge, M.
    O'Gorman, P.
    Song, K.
    Sternas, L.
    Biyukov, T.
    Hong, K.
    Herring, J.
    Yu, X.
    Zaki, M. H.
    San Miguel, J.
    HAEMATOLOGICA, 2016, 101 : 531 - 531
  • [2] A POOLED ANALYSIS OF THE IMPACT OF AGE ON OUTCOMES IN PATIENTS WITH REFRACTORY OR RELAPSED AND REFRACTORY MULTIPLE MYELOMA TREATED WITH POMALIDOMIDE plus LOW-DOSE DEXAMETHASONE
    Palumbo, A.
    Dimopoulos, M. A.
    Richardson, P. G.
    Siegel, D. S.
    Cavo, M.
    Corradini, P.
    Weisel, K. C.
    Delforge, M.
    Chen, C.
    Goldschmidt, H.
    Jagannath, S.
    Lockhorst, H. M.
    Moreau, P.
    Plesner, T.
    Sternas, L.
    Peluso, T.
    Hong, K.
    Herring, J.
    Yu, X.
    Zaki, M. H.
    San Miguel, J.
    HAEMATOLOGICA, 2016, 101 : 535 - 536
  • [3] Pembrolizumab, pomalidomide, and low-dose dexamethasone for relapsed/refractory multiple myeloma
    Badros, Ashraf
    Hyjek, Elizabeth
    Ma, Ning
    Lesokhin, Alexander
    Dogan, Ahmet
    Rapoport, Aaron P.
    Kocoglu, Mehmet
    Lederer, Emily
    Philip, Sunita
    Milliron, Todd
    Dell, Cameron
    Goloubeva, Olga
    Singh, Zeba
    BLOOD, 2017, 130 (10) : 1189 - 1197
  • [4] Pomalidomide plus low-dose dexamethasone in patients with relapsed/refractory multiple myeloma and moderate renal impairment: a pooled analysis of three clinical trials
    Siegel, David S.
    Weisel, Katja C.
    Dimopoulos, Meletios A.
    Baz, Rachid
    Richardson, Paul
    Delforge, Michel
    Song, Kevin W.
    San Miguel, Jesus F.
    Moreau, Philippe
    Goldschmidt, Hartmut
    Cavo, Michele
    Jagannath, Sundar
    Yu, Xin
    Hong, Kevin
    Sternas, Lars
    Zaki, Mohamed
    Palumbo, Antonio
    LEUKEMIA & LYMPHOMA, 2016, 57 (12) : 2833 - 2838
  • [5] OPTIMIZATION OF POMALIDOMIDE PLUS LOW DOSE DEXAMETHASONE IN REFRACTORY/RELAPSED MYELOMA MULTIPLE PATIENTS
    De Miguel, D.
    Gil, A.
    Golbano, N.
    Diaz, M.
    Guillen, H.
    Vazquez, A.
    Pinedo, B.
    HAEMATOLOGICA, 2017, 102 : 790 - 791
  • [6] Adverse event (AE) management in patients (pts) with relapsed and refractory multiple myeloma (RRMM) taking pomalidomide (POM) plus low dose-dexamethasone (LoDEX): A pooled analysis from 3 clinical trials.
    Moreau, Philippe
    Dimopoulos, Meletios A.
    Richardson, Paul G.
    Siegel, David Samuel DiCapua
    Palumbo, Antonio
    Cavo, Michele
    Corradini, Paolo
    Weisel, Katja
    Delforge, Michel
    O'Gorman, Peter
    Song, Kevin W.
    Sternas, Lars Axel
    Peluso, Teresa
    Hong, Kevin
    Herring, Jennifer
    Yu, Xin
    Zaki, Mohamed H.
    Miguel, Jesus San
    JOURNAL OF CLINICAL ONCOLOGY, 2016, 34 (15)
  • [7] Selinexor Plus Pomalidomide and Low Dose Dexamethasone (SPd) in Patients with Relapsed or Refractory Multiple Myeloma
    Chen, Christine I.
    Sutherland, Heather J.
    Kotb, Rami
    Sebag, Michael
    White, Darrell J.
    Bensinger, William
    Gasparetto, Cristina J.
    Leblanc, Richard
    Venner, Christopher P.
    Lentzsch, Suzanne
    Schiller, Gary J.
    Lipe, Brea
    Del Col, Aldo
    Shah, Jatin J.
    Jeha, Jacqueline
    Saint-Martin, Jean-Richard
    Kauffman, Michael G.
    Shacham, Sharon
    Bahlis, Nizar
    BLOOD, 2018, 132
  • [8] Isatuximab plus pomalidomide/low-dose dexamethasone versus pomalidomide/low-dose dexamethasone in patients with relapsed/refractory multiple myeloma (ICARIA-MM): final overall survival analysis
    Richardson, Paul
    Perrot, Aurore
    San-Miguel, Jesus
    Beksac, Meral
    Spicka, Ivan
    Leleu, Xavier
    Schjesvold, Fredrik
    Moreau, Philippe
    Dimopoulos, Meletios A.
    Huang, Jeffrey Shang-Yi
    Minarik, Jiri
    Cavo, Michele
    Prince, H. Miles
    Malinge, Laure
    Dubin, Franck
    Morisse, Mony
    Anderson, Kenneth
    CLINICAL LYMPHOMA MYELOMA & LEUKEMIA, 2022, 22 : S32 - S32
  • [9] Analysis of Pomalidomide Plus Low-Dose Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma with Vs without Moderate Renal Impairment
    Siegel, David S.
    Weisel, Katja C.
    Dimopoulos, Meletios A.
    Baz, Rachid
    Richardson, Paul G.
    Delforge, Michel
    Song, Kevin
    San Miguel, Jesus
    Moreau, Philippe
    Yu, Xin
    Hong, Kevin
    Sternas, Lars
    Zaki, Mohamed H.
    Palumbo, Antonio
    BLOOD, 2015, 126 (23)
  • [10] Pomalidomide plus low-dose dexamethasone in relapsed refractory multiple myeloma after lenalidomide treatment failure
    Siegel, David S.
    Schiller, Gary J.
    Song, Kevin W.
    Agajanian, Richy
    Stockerl-Goldstein, Keith
    Kaya, Hakan
    Sebag, Michael
    Samaras, Christy
    Malek, Ehsan
    Talamo, Giampaolo
    Seet, Christopher S.
    Mouro, Jorge
    Pierceall, William E.
    Zafar, Faiza
    Chung, Weiyuan
    Srinivasan, Shankar
    Agarwal, Amit
    Bahlis, Nizar J.
    BRITISH JOURNAL OF HAEMATOLOGY, 2020, 188 (04) : 501 - 510